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Regulatory Information Management

Bring Regulatory Data, Processes, Submissions, and Compliance Together.

In today’s global life sciences environment, Regulatory Affairs teams manage far more than submissions. As regulatory complexity increases, managing the lifecycle and data through spreadsheets, disconnected databases, emails, different local/cloud document stores and manual processes creates visibility gaps and increases the risk of missed activities, inconsistent data, and compliance delays.

Regulatory Information Management (RIM) provides a structured, centralized approach to managing regulatory information and processes throughout the product lifecycle. With Visu RIM, organizations can establish a single source of regulatory information, connect regulatory processes, standardize workflows, and provide real-time visibility into regulatory activities across markets.

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The Business Impact from Visu to companies

Empowering life sciences organizations with complete control, visibility, and automation across global regulatory operations.

validated-compliance

Improve Compliance

Maintain stronger control over regulatory requirements, activities, and commitments.

increase-regulatory-visibility

Increase Regulatory Visibility

Create a single view of global regulatory operations.

agentic-ai

Reduce Manual Effort

Automate repetitive tracking, workflows, notifications, and reporting.

faster-review-cycles

Accelerate Regulatory Operations

Improve coordination across submissions, registrations, approvals, and post-approval activities.

high-risk-human-error

Reduce Operational Risk

Minimize reliance on disconnected spreadsheets, emails, and manual trackers.

real-time-visibility

Improve Decision-Making

Give regulatory leaders access to timely operational and compliance insights.

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Scale Globally

Support different countries, products, regulatory frameworks, and business processes within a common platform.

RIM Capabilities Across the Regulatory Lifecycle

Connect Every Regulatory Process Through One RIM Framework

A modern RIM solution connects the activities so regulatory teams can manage the complete regulatory
lifecycle, rather than individual processes in isolation.

product-registration

Product Registration & Market Authorization Management

Maintain a centralized view of product registrations and market authorizations across countries and regions.

RIM can help Regulatory Affairs teams manage:
  • Product and registration information
  • Marketing authorizations
  • Licenses and certificates
  • Country-specific registrations
  • Registration status
  • Approval and expiry information
  • Post-approval activities
  • Regulatory milestones

This creates a consistent regulatory view of where products are registered, what status they have, and what actions are required.

regulatory-requirements

Regulatory Requirements & Compliance Management

Global regulatory compliance requires organizations to understand what is required in each market—and continuously assess whether those requirements are being met.

RIM provides a framework for connecting:

Regulatory Requirement → Product → Market → Obligation → Activity → Evidence → Compliance Status

This allows Regulatory Affairs to move beyond static requirements databases toward actionable compliance management.

Teams can identify gaps, monitor obligations, and maintain visibility into regulatory activities across markets.

regulatory-intelligence

Regulatory Intelligence & Change Management

Regulations continuously evolve. New guidance, requirements, standards, authority expectations, and country-specific changes can create downstream impacts across products and regulatory processes.

A connected RIM environment allows regulatory intelligence to feed directly into regulatory operations.

From Change to Action:

Monitor: Identify relevant regulatory changes.

Assess: Determine potential impact on products, markets, submissions, labeling, documentation, and regulatory commitments.

Assign: Create actions and assign responsibilities.

Execute: Manage the resulting regulatory activities through controlled workflows..

Track: Monitor completion and maintain visibility into the status of regulatory actions.

regulatory-impact-assessment

Regulatory Impact Assessment

Regulatory change is only valuable to the organization when its impact can be understood and acted upon.

RIM can provide the operational foundation for connecting regulatory intelligence with Regulatory Impact Assessment (RIA).

Assess the potential impact of regulatory changes across:
  • Products
  • Countries
  • Registrations
  • Submissions
  • Regulatory documents
  • Labeling
  • Commitments
  • Regulatory activities
  • Internal stakeholders

This transforms regulatory change management from a reactive exercise into a structured, traceable process.

submission-planning

Submission Planning & Tracking

Regulatory submissions involve multiple stakeholders, documents, activities, milestones, and dependencies.

RIM provides centralized oversight of the submission lifecycle.

Manage:
  • Submission plans
  • Submission types
  • Country and regional activities
  • Submission milestones
  • Content requirements
  • Document readiness
  • Review and approval workflows
  • Submission status
  • Regulatory commitments

Visu supports management of submission types such as MAAs, NDAs, and variations through workflow-driven processes.

health-authority-interaction

Health Authority Interaction Management

Regulatory interactions continue long after a submission is made.

Centralize health authority communications, requests for information, questions, deficiencies, responses, and commitments.

This provides Regulatory Affairs with a clear record of::

What was requested → Who owns it → What is the response → When is it due → What was submitted → What remains open

The result is improved accountability and reduced risk of missed regulatory commitments.

regulatory-documents-publishing

Regulatory Documents & Publishing

Regulatory information does not exist independently of regulatory content.

RIM can connect regulatory data and processes with document management, submission management, labeling, and publishing environments.

Visu supports integration with document management, submission, and labeling systems, allowing organizations to create a connected regulatory ecosystem rather than isolated applications.

regulatory-reporting

Regulatory Reporting & Analytics

Regulatory leaders need more than lists of activities. They need actionable insight.

RIM dashboards can provide visibility into:
  • Submission volumes
  • Regulatory workload
  • Activity status
  • Submissions
  • Approval timelines
  • Regional performance
  • Outstanding actions
  • Compliance gaps
  • Regulatory commitments

Visu supports predefined and custom reporting and can connect regulatory data with business intelligence tools.

One Connected Regulatory Lifecycle

Regulatory Intelligence Regulatory Intelligence
→
Impact Assessment Impact Assessment
→
Planning Planning
→
Registration Registration
→
Submission Submission
→
Health Authority Interaction Health Authority Interaction
→
Approval Approval
→
Post-Approval Post-Approval
→
Ongoing Compliance Ongoing Compliance

Make Visu RIM the Digital Foundation for Regulatory Affairs

Regulatory Information Management is no longer simply about maintaining a database of registrations.

It is about connecting regulatory data, intelligence, processes, people, documents, submissions, and compliance activities into a single, actionable regulatory ecosystem.

With Visu, organizations can move from fragmented regulatory tracking to an integrated, data-driven approach to regulatory operations-supporting the full lifecycle from regulatory planning and product registration through submissions, health authority interactions, approvals, and ongoing compliance.

Ready to Transform Regulatory Information management?

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Frequently Asked Questions

Common questions about Visu RIM platform and capabilities.

faq-question

What is Visu RIM and how does it support life sciences organizations?

Visu RIM (Regulatory Information Management) is a platform designed for global life sciences organizations to centralize regulatory data, connect end-to-end regulatory processes, and ensure continuous compliance across markets. It serves as a single source of truth for managing the entire product lifecycle—from planning and submissions to health authority interactions and post-approval commitments.

faq-question

What core capabilities are included in the Visu RIM platform?

Visu RIM connects key regulatory activities into a single framework, including:

Product Registration & Market Authorization Management: Tracks registrations, marketing licenses, certificates, and approval statuses globally.

Regulatory Requirements & Compliance Management: Maps requirements directly to products, markets, and compliance evidence.

Regulatory Intelligence & Change Management: Monitors regulatory changes, performs impact assessments, and automates downstream actions.

Submission Planning & Tracking: Manages submission types (e.g., MAAs, NDAs, variations), document readiness, and approval workflows.

Health Authority Interaction Management: Logs communications, requests for information, deficiencies, and binding commitments.

Regulatory Reporting & Analytics: Provides dashboards for workload, approval timelines, compliance gaps, and regional performance.

faq-question

How does Visu RIM improve regulatory compliance and operational visibility?

By eliminating disconnected spreadsheets, emails, and manual tracking databases, Visu RIM provides real-time, global visibility into regulatory operations. It automates repetitive workflows, tracking, and notifications to lower operational risk, eliminate visibility gaps, and ensure no regulatory commitment or activity deadline is missed.

faq-question

How does Visu RIM handle regulatory intelligence and Regulatory Impact Assessments (RIA)?

Visu RIM connects evolving global guidance and authority expectations directly to regulatory operations through a structured flow:

Monitor: Identifies relevant regulatory updates.

Assess: Evaluates impacts across products, countries, submissions, labeling, and internal commitments.

Assign & Execute: Creates and assigns controlled, workflow-driven tasks.

Track: Monitors completion to transform regulatory change management from a reactive effort into a traceable process.

faq-question

Can Visu RIM integrate with external document management and publishing systems?

Yes, Visu supports integration with external document management, submission management, and labeling/publishing systems. This creates a connected regulatory ecosystem that unifies regulatory data, processes, and content without maintaining isolated applications.

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